This invention relates generally to pH measurement of body fluid, such as vaginal moisture, and more particularly to a rapid and easily performed method of obtaining such measurement, as well as apparatus to perform the method. The invention also relates to detection of pathogenic bacteria in the vagina, for example in association with such pH measurement, whereby more complete testing can easily be achieved.
There is continual need for improvements in testing and measurement methods, as referred to; and in particular there is need for effecting such testing and measurements without introduction of possibly toxic materials or substances into the vagina or other body cavities or parts.
It is a major object of the invention to provide improved testing and measurement methods and procedures that meet the above need, and overcome prior difficulties, as referred to.
Basically, an important method provided by the invention includes the steps
a) providing an indicator that exhibits a characteristic color when contacted with vaginal or other body tissue moisture, the color being a function of moisture pH,
b) obtaining a vaginal or tissue moisture sample and transferring moisture from the sample to the indicator, outside the vagina or tissue sampled, whereby the indicator then exhibits a characteristic color, which is a function of pH of the moisture,
c) providing a color comparison measurement means, and comparing the indicator characteristic color with the color comparison measurement means.
As will appear, a vaginal or tissue moisture receiver is typically provided to be supported on a carrier, to be manipulated to obtain the vaginal or tissue moisture sample on the receiver, for transfer to the indicator, outside the vagina or other anatomic site.
It is another important object to provide a package which includes structure supporting said indicator and said carrier for the receiver, and including the step of removing the carrier from the package for use in obtaining said moisture sample on the receiver.
As will be seen, the color comparison measurement means is typically provided to extend proximate said indicator, in or on the package; and may be provided to include portions of varying color that are arranged in one of the following ways:
i) in a generally linear sequence,
ii) in a sequence to at least partially surround the indicator.
Further, the indicator may include multiple sections, and the color comparison measurement means typically includes color swatches, at least one swatch located proximate each indicator.
Another object is to provide the carrier in the form of an inserter, or stick, and the receiver is supported proximate an end of the stick, the receiver provided in the form of a swab, and a shoulder is provided on the stick to limit depth of insertion of the swab, into the vagina.
A further object is to provide a second indicator supported by the package, the second indictor including a reactant or reactants characterized as changing color when contacted with moisture containing amine, and including transferring moisture from the sample to the second indicator, outside the vagina, whereby a change in color at the second indicator indicates the presence of pathogenic bacteria in such moisture.
It is an additional object to repeat the basic pH detector method, at intervals over a time period sufficient to detect changes in vaginal or other tissue moisture pH levels, indicative of need for estrogen, antibiotics or other therapy.
Yet another object is to provide apparatus that includes:
a) a package,
b) a pH detector on the package,
c) the detector including a pH indicator responsive to reception of vaginal or other tissue moisture, to change color indicative of pH level, when such moisture is transferred to the indicator, outside the body.
A yet further object is to provide a comprehensive method that includes, in combination
a) providing an indicator that exhibits a characteristic color when contacted with vaginal or other tissue moisture, said color being a function of moisture pH,
b) obtaining a vaginal or other tissue moisture sample and transferring moisture from the sample to the indicator, outside the body, whereby the indicator then exhibits said characteristic color, which is a function of pH of said moisture,
c) providing a color comparison measurement means, and comparing said indicator characteristic color with said color comparison measurement means.
In the above form of apparatus, the pH detector may typically include an indicator or indictors responsive to reception of vaginal or tissue moisture to change to a color or colors indicative of pH level, and there being color comparison measurement means associated with said indicator or indicators, on a package.
Further, the color comparison measurement means typically may extend close to and at least part way about said indicator, whereby a small indicator area may be effectively employed for reception of a minimum amount of collected moisture.
An additional object is to provide a pH test for presence of amniotic fluid, as may collect on a surface.
These and other objects and advantages of the invention, as well as the details of an illustrative embodiment, will be more fully understood from the following specification and drawings, in which: